Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.

Boston Medical Group

Status: Enrolling

Conditions: Premature (Early) Ejaculation; Erectile Dysfunction; Pelvic Floor; Weak; Premature Ejaculation

Treatments: Device: Perineal electromyographic biofeedback; Device: Electrical stimulation; Behavioral: Therapeutic exercises

Study type: Interventional

Funder types: Industry

Identifiers

NCT06425211

BMGC-6

Details and patient eligibility

About

The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. The main question to answer is:

What is the effectiveness of pelvic floor therapy (electrostimulation, biofeedback, and therapeutic exercise) for the treatment of patients with erectile dysfunction and or premature ejaculation?

Patients will:

• Have an initial consultation of pelvic floor rehabilitation before therapy.
• Be given pelvic floor therapy.
• Have a secondary consultation of pelvic floor rehabilitation after therapy.

Three intervention groups will be included: Group 1: Patients with premature ejaculation Group 2: Patients with erectile dysfunction Group 3: Patients with erectile dysfunction and premature ejaculation.

Full description

The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation.

Methodology: Pre-post study. Erectile function or intravaginal latency time will be evaluated before and after pelvic floor therapy, in three groups of patients, independently:

• Group 1: Patients with premature ejaculation

• Group 2: Patients with erectile dysfunction

• Group 3: Patients with erectile dysfunction and premature ejaculation

  66 patients will be included and will receive 24 sessions of pelvic floor therapy during 12 weeks. Outcomes will be evaluated at the end of therapy (12 weeks), 3 and 6 months follow-up.

Enrollment: 66 estimated patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Overall:

• Men over 18 years of age
• Erectile dysfunction or premature ejaculation for at least 6 months
• Sexual activity with a heterosexual partner at least once a week
• Signing of informed consent before the start of the study

For the premature ejaculation group:

• Premature ejaculation according to the International Society of Sexual Medicine (ISSM) criteria
• Premature Ejaculation Diagnosis Tool (PEDT) questionnaire score greater than 11

For the erectile dysfunction group:

• Clinical diagnosis of primary erectile dysfunction
• International Index Erectile Function - Erectile Function domain (IIEF-EF) score less than 26

Exclusion criteria

• Pharmacological treatment for erectile dysfunction or premature ejaculation in the last 3 months
• Erection Hardness Score (EHS) greater than 3 for patients with erectile dysfunction
• History of hypogonadism or suspected hypogonadism due to Aging Males Symptoms (AMS) score greater than 36 for patients with erectile dysfunction
• History of pelvic radiotherapy
• Pacemaker or cardiac arrhythmia, epilepsy
• History of spinal cord trauma or spinal surgeries.
• Inability to attend therapies or controls
• Illiteracy or cognitive disability that prevents you from completing the questionnaires
• Psychiatric, psychological disorders, or cognitive deficiencies
• Injuries in the area of application of the therapy
• Active pelvic organ cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Erectile Dysfunction

Experimental group

Description:

The therapy depends if patient is classified within muscular hyperactivity or muscular hypoactivity. For muscular hypoactivity: Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: Session 24 For muscular hyperactivity they will be given: Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation

Treatment:

Behavioral: Therapeutic exercises

Device: Electrical stimulation

Device: Perineal electromyographic biofeedback

Premature Ejaculation

Experimental group

Description:

Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-15 Muscle workout: sessions 16-19 Functional training: sessions 20-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation

Treatment:

Behavioral: Therapeutic exercises

Device: Electrical stimulation

Device: Perineal electromyographic biofeedback

Premature Ejaculation + Erectile Dysfunction

Experimental group

Description:

Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-12 Muscle workout: sessions 13-20 Functional training: sessions 20-23 Final evaluation: session 24 These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation

Treatment:

Behavioral: Therapeutic exercises

Device: Electrical stimulation

Device: Perineal electromyographic biofeedback